FDA Wants Allergan to Pull Botox Ads and Brochures

Pharmaceuticals: The firm says it won't comply, maintaining it has worked diligently to be accurate.

The Food and Drug Administration has demanded that Allergan Inc. "immediately cease distribution" of television advertisements and patient brochures for Botox Cosmetic, charging that they violate federal law and contain information that is misleading to consumers.

The notice-of-violation letter sent to Irvine-based Allergan was one step short of an FDA warning letter and gives the company 10 days to provide a written response. A warning letter, in which the agency outlines enforcement action that would be taken by the Justice Department, might come next if Allergan refuses to comply.

Among other things, the FDA said Allergan's patient brochure was misleading about everything from how long the Botox injection procedure lasts (usually four months) to which specific wrinkle it had been approved for. The FDA also said the Allergan Web site for physicians was confusing with regard to how much the Botox solution should be diluted.

The FDA said most companies comply with such notices, but Allergan responded angrily Monday, saying it would not pull the advertisements or the brochure and that it was disappointed and frustrated by the FDA letter.

"We strongly disagree on all points," said Allergan spokeswoman Christine Cassiano, adding that the company "worked diligently" with the agency to produce accurate materials about Botox Cosmetic, the nation's most widely used cosmetic procedure. Cassiano said that there have been several conversations and correspondence between the company and the FDA and that the agency never indicated there was a problem.

The FDA has responsibility for policing ads for drugs and for biological products such as botulinum toxin type A, as Botox is formally known; it was approved by the FDA this year for use on a specific wrinkle that develops between the eyebrows and the forehead.

Mary Malarkey, director of case management for the FDA's Center for Biologics Evaluation and Research and author of the letter, maintained that Allergan was in violation of federal standards.

But several doctors interviewed Monday were hard-pressed to understand the FDA's concerns and said they generally found Allergan's information accurate.

"I think they were more careful than most" companies that advertise, said Dr. Nina Patel, who runs a cosmetic, laser and surgical clinic in Marina del Rey.

Dr. Richard Glogau, a clinical professor of dermatology at UC San Francisco who worked on the FDA study of the procedure and is a paid consultant for Allergan, said doctors were not concerned about the advertisements, only about unqualified physicians trying to perform the procedure.

"The ads and the brochures are not misleading," said Dr. Stuart Kaplan, a Beverly Hills dermatologist who has given botox injections to patients for several years. "They weren't ever supposed to take the place of a doctor's advice."

Allergan shares fell 65 cents to $56.44 on the New York Stock Exchange.